DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Exposure
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall (Fresenius product category) with no reported illnesses, injuries, or deaths. The hazard is temperature exposure with unknown clinical impact, and no harm has been reported. Class III recalls are typically scored 1 or 2 per the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose (Low magnesium, Low Calcium) in two package sizes: 2500 mL (NDC 49230-209-94) and 2000 mL packs of 5 (NDC 49230-209-92). A total of 39 cases have been recalled nationwide.
The recall was initiated because the product was exposed to temperatures outside the specified limits. The affected lot numbers are 20PU02010 (2500 mL, expiration June 2022) and 20SU04033 (2000 mL, expiration July 2022).
DELFLEX is a prescription dialysis solution administered intraperitoneally for patients requiring peritoneal dialysis. Healthcare providers and patients who have this product should discontinue use and contact Fresenius Medical Care for guidance on replacement product.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 39
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) 20PU02010
- Exp. date June 2022 and b) 20SU04033
- Exp. date July 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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